The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms (BY1023/NL511)

May 4, 2012 updated by: Takeda

The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms

The aim of the study is to compare two different endpoint measures: heartburn as assessed by the physicians versus gastroesophageal reflux disease (GERD)-related symptoms as assessed by the patient using the ReQuest™ questionnaire. The assessment is made in GERD-patients treated with a daily dose of 40 mg oral pantoprazole over an 8-week period.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • BT Oss, Netherlands, 5342
        • Altana Pharma/Nycomed
      • Den Helder, Netherlands, 1782 GZ
        • Altana Pharma/Nycomed
      • EH Geldrop, Netherlands, 5664
        • Altana Pharma/Nycomed
  • Switzerland
      • Basel, Switzerland, 4001
        • Altana Pharma/Nycomed
      • Basel, Switzerland, 4051
        • Altana Pharma/Nycomed
      • Biel/Bienne, Switzerland, 2502
        • Altana Pharma/Nycomed
      • Bülach, Switzerland, 8180
        • Altana Pharma/Nycomed
      • Locarno, TI., Switzerland, 6600
        • Altana Pharma/Nycomed
      • Luzern, Switzerland, 6003
        • Altana Pharma/Nycomed
      • Luzern, Switzerland, 6004
        • Altana Pharma/Nycomed
      • Reinach BL, Switzerland, 4153
        • Altana Pharma/Nycomed
      • Sion, Switzerland, 1950
        • Altana Pharma/Nycomed
      • Thun, Switzerland, 3600
        • Altana Pharma/Nycomed
      • Winterthur, Switzerland, 8400
        • Altana Pharma/Nycomed
      • Zürich, Switzerland, 8050
        • Altana Pharma/Nycomed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • Outpatients of at least 18 years of age
  • History of GERD-related symptoms of at least 6 months prior to baseline visit
  • Endoscopically-confirmed GERD or non-erosive GERD

Exclusion Criteria:

  • Zollinger-Ellison syndrome or other gastric hypersecretory condition
  • Acute peptic ulcer and/or ulcer complications
  • Pyloric stenosis
  • Severe or unstable cardiovascular, pulmonary, and/or endocrine disease
  • Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of reliable contraception in women of child-bearing potential
  • Intake of any medication for the purpose of eradication of Helicobacter pylori (H. pylori) within the last 28 days prior to study start
  • Intake of systemic glucocorticoids or non-steroidal anti-inflammatory drugs including cyclooxygenase-2 (COX-2) inhibitors for more than 3 consecutive days within the last 28 days prior to study start; with the exception of acetylsalicylic acid not more than 150 mg per day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1.
40 mg Pantoprazole
Drug: Pantoprazole
40 mg Pantoprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of misclassification on day 14 based on heartburn as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-gastrointestinal (GI) questionnaire
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of misclassification on day 14 based on acid regurgitation as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-GI questionnaire
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Principal Investigator: M. Oudkerk Pool, Prof., Isala Klieniken, Zwolle, The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ACTUAL)

October 1, 2007

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

March 2, 2007

First Submitted That Met QC Criteria

March 20, 2007

First Posted (ESTIMATE)

March 21, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY1023/NL511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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